An interventional study of ENHANCE intervention (health systems) in HIV Infections, Hypertension and Diabetes Mellitus, sponsored by University of KwaZulu. Completed at 32 sites in South Africa. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-02-24.
Sponsored by University of KwaZulu · Not applicable, Interventional, and Other
The goal of this study is to determine the effect of the ENHANCE intervention in improving clinical outcomes and evaluating the effects of the intervention on implementation processes and outcomes. The specific questions it aims to answer are:
To test and estimate the effect of the intervention in people with MLTCs attending
PHCs on:
i. Detection of, and initiation of treatment for, additional chronic conditions ii. Treatment intensification and changes in medication iii. Control of chronic conditions iv. patient reported health-related quality of life and functioning v. health care utilisation and adherence vi. costs of health care
The participants in the control group will receive usual care at their primary health care facility, which includes the use of the Practical Approach to Care Kit (PACK) or Adult Primary Care (APC) clinical decision support tool. Participants in the intervention group will receive care for their multiple chronic condition by a clinician trained to use the ENHANCE clinical decision support tool (intervention tool), and receive two CHW visits in their home to provide treatment literacy and adherence support.
Control facilities Participants in control facilities will continue to receive usual care. Primary health care of long-term conditions is delivered free-at-point-of-care in public sector primary care facilities which includes the management of HIV, NCDs and mental health problems, according to South Africa's Ideal Clinic and Integrated Clinical Services Management model. This care model, which has combined the long-term care of HIV together with NCDs within each facility, has greatly enabled the feasibility of further interventions specifically addressing MLTCs and includes the Adult Primary Care (APC) or PACK clinical guidance. Patients attending these chronic services usually attend the same clinic regularly, 3 to 6-monthly for periodic monitoring of their chronic conditions. Chronic medication is collected monthly either at the facility (through fast-track queues), or through decentralised chronic medication dispensing systems which provide for collection from a range of sites including community venues (e.g. halls), wellness or adherence clubs, trailers, retail pharmacies (in KZN) or e-Lockers.
Intervention clinics
Participants in intervention clinics will continue with usual care as described for control clinics but in addition will receive the ENHANCE health systems intervention comprising tools and implementation strategies that have been co-developed with stakeholders through an iterative process, drawing on:
i. Evidence on the commonest MLTC combinations ii. Scoping reviews conducted on effectiveness of MLTCS interventions and systems barriers and enablers of person-centred care for MLTCs in LMICs iii. Provincial and district learning collaborative workshops with stakeholders from KZN and Western Cape.
iv. Clinical working groups with clinicians and health workers, a Guidance Oversight Board v. Input from our ENHANCE advocacy academy of 16 people living with MLTCs in the Western Cape and KZN
The intervention targets screening and early identification of other chronic conditions; improving follow-up and support for people with a new diagnosis, at risk of treatment failure (e.g. poorly controlled HIV or diabetes), and strengthen bi-directional referral pathways between the facility and community. Tools and implementation strategies will be layered into existing architecture of the chronic care system and support provision of more person-centred and empowering care across the treatment cascade.
Tools to support the implementation of the health systems intervention comprise:
Implementation strategies include:
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's enrollment of 1,837 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →University of KwaZulu is the lead sponsor of 34 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Receiving care for at least two of the following conditions, with at least one of the first five listed conditions being uncontrolled or patients indicated as struggling with the management of their condition:
i. (Self-reported current treatment). ii. hypertension (Self-reported current treatment. iii. diabetes (Self-reported current treatment). iv. asthma (Self-reported current treatment). vi. depression (Self-reported current treatment). vii. previous myocardial infarction (self-reported). viii. previous stroke (self-reported history).
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1. Treatment literacy in chronic condition waiting rooms/pick-up points (posters, health promotion talks) 2. 1-2 longer consultations with ENHANCE guide trained clinician 3. Treatment literacy event - a contact between a CHW and a person with MLTC in their home (hopefully with carer), at 2 weeks and 4 weeks, using Health Diary 4. Referrals to additional adherence counselling if necessary
Other: ENHANCE intervention (health systems)
Usual care at primary health care clinic, which includes consultation with a clinician using the PACK/APC guide. No additional support is usually provided for care of MLTCs.
The intervention tools include a consolidated clinical decision support tool, health education posters, waiting room talks, medication list for treatment literacy and a patient health diary. Training session are delivered at all intervention sites and include 1 facility team session to introduce the ENHANCE study to the whole team; 3 clinical sessions for nurses and doctors; 2 sessions for community health workers and health promoters; Maintenance sessions to keep the ENHANCE intervention going for at least 12 months
Composite outcome: Diagnosis and treatment initiation for a new condition, intensification or change of treatment for a condition treated at enrolment, or improved control for a condition not optimally controlled at enrolment.
Number of participants who meet any of the following criteria during follow-up: 1. . Diagnosis and initiation of treatment during follow-up of one or more additional chronic conditions, 2. . Intensification or change of treatment during follow-up for at least one of the chronic conditions present and treated at enrolment, or, 3. . Improved control of at least one condition that was not optimally controlled at baseline, defined as follows: HIV - viral suppression (viral load \<50 copies/mL); hypertension - systolic blood pressure\<140 mmHg and diastolic blood pressure less than 90mmHg; diabetes - HbA1c \<8%, asthma - Asthma Control Test score ≥16, depression - Patient Health Questionnaire 8 (PHQ-8) \<10
Time frame: 12 months
Diagnosis and initiation of treatment during follow-up of one or more additional chronic conditions
The number of participants having a diagnosis and treatment initiation during follow-up of one or more additional chronic conditions
Time frame: 12 months
Intensification or change of treatment during follow-up for at least one of the chronic conditions present and treated at enrolment
The number of participants with intensification or change of treatment during follow-up for at least one of the chronic conditions present and treated at enrolment
Time frame: 12 months
Improved control of at least one condition that was not optimally controlled at baseline
The number of participants with improved control of at least one condition that was not optimally controlled at baseline, defined as follows: HIV - viral suppression (viral load \<50 copies/mL); hypertension - systolic blood pressure\<140 mmHg and diastolic blood pressure less than 90mmHg; diabetes - HbA1c \<8%, asthma - Asthma Control Test score ≥16, depression - Patient Health Questionnaire 8 (PHQ-8) \<10
Time frame: 12 months
World Health Organisation Disability Assessment Schedule 2.0 score
Mean functional disability score assessed using the 12-item WHODAS-2.0 (World Health Organisation Disability Assessment Schedule 2.0) tool. The scores range from 0-100, with higher scores indicating more functional limitations/disability
Time frame: 12 months
Health-related quality of life EuroQol 5-Dimension 5-Level score
Mean health-related quality of life score assessed using the EuroQol 5D-5L (EQ5D-5L). The EQ5D-5L score ranges from -0.493 (indicating the worst health state) to 1 (indicating the best health state
Time frame: 12 months
Health-related quality of life visual analogue scale score
Mean self-reported health-related quality of life score assessed using a visual analogue scale (VAS). The VAS score ranges from 0-100, with higher scores indicating better health status.
Time frame: 12 months
Patient Assessment of Chronic Illness Care
Mean Patient Assessment of Chronic Illness Care (PACIC) score. The score ranges from 1 - 5, with lower scores indicating worse satisfaction with chronic care and higher scores indicating more satisfaction
Time frame: 12 months
Patient experience with treatment and self-management
Mean scores for patient experience with treatment and self-management (PETS), assessed using a shortened version of the PETS tool. The tool has no overall score and uses domain scores with different ranges. Lower scores indicate more difficulty, and higher scores indicate more ease.
Time frame: 12 months
Patient Health Questionnaire-8 (PHQ-8) score
Mean scores for depressive symptoms assessed using the patient health questionnaire-8 (PHQ-8) tool. The score ranges from 0-24, with higher scores indicating worse depressive symptoms
Time frame: 12 months
Social Support
Number of patients reporting having social support for their care and medical needs, and mean social support score
Time frame: 12 months
Healthcare utilisation - Number of clinic visits
Number of clinic visits
Time frame: 12 months
Healthcare utilisation - Number of hospital outpatient visits
Number of hospital outpatient visits
Time frame: 12 months
Healthcare utilisation - hospital admissions
Number of hospital admissions
Time frame: 12 months
Healthcare utilisation - hospital admission days
Number of hospital in-patient days
Time frame: 12 months
Health care costs
The costs of accessing healthcare
Time frame: 12 months
Implementation
Reach, adoption and implementation, and maintenance of the ENHANCE intervention: * Exposure of PHC staff and patients to elements of the intervention and implementation strategy, * Integration of intervention components into care * Appropriateness of new diagnoses and treatment * Patient, clinician and CHW perceptions of the acceptability of the ENHANCE intervention and associated barriers and facilitators to its implementation
Time frame: 12 months
Plan to share: Yes — Individual participant data that underlie the results reported, after deidentification (text, tables, figures, and appendices).
Supporting information: Study protocol
Time frame: Beginning 9 months and ending 36 months following article publication.
Access criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
Ran from Sep 2023 to primary completion in Nov 2025, 25 months.
Of 393 non-industry interventional studies with no phase under HIV Infections, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 45. This study's 25 months is below that.
Counting every sponsor, half of 402 studies reached it within 28 months; a quarter within 16 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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University of KwaZulu